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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094); Osteolysis (2377); Reaction (2414); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: product id: vngd ti fem ps 65mm lt, catalog #: cp113639. Lot # 390450. Product id: biomet ilok pri tib tray 63mm, catalog #: 141211, lot # 983340. Product id: vngd ps tib brg 11x63/67, catalog #: 183621, lot # 649610. Product id: series a asymmetric pat 31x8, catalog #: 184792, lot # 711690. Product id: simplex cement, catalog #: unknown, lot #: unknown. Multiple mdr: 0001825034-2020-03853, 0001825034-2020-03854. Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Patient alleges to be allergic to zirconium and chromium. Subsequently, the patient has indicated for revision due to metal allergies, pain, swelling, stiffness and synovitis. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameBIOMET FINNED PRI STEM 40MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10793349
MDR Text Key214824783
Report Number0001825034-2020-04011
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number141314
Device Lot Number530850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
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